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Healthy Skepticism Library item: 12821

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Researcher: FDA Was Too Slow On Trasylol: Tells 60 Minutes He Estimates 22,000 Lives Could Have Been Saved
CBS News 60 Minutes 2008 Feb 17
http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900.shtml


Full text:

A renowned researcher calculates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago, when his study revealed widespread death associated with it.

The researcher, Dr. Dennis Mangano, also tells 60 Minutes correspondent Scott Pelley that Bayer, the drug’s maker, failed to tell the FDA about negative results of their own Trasylol study and that the company’s failure placed the drug’s success before patient well-being.

Mangano’s interview will be broadcast this Sunday, Feb. 17, at 7 p.m. ET/PT.

Bayer suspended sales of the expensive drug, used to limit bleeding in heart surgery, last year at the request of the FDA, after a Canadian study of Trasylol was stopped because of patient deaths, causing a ban of the drug in Germany, where Bayer is based. At the height of its use, Trasylol was given to about a third of all heart bypass patients in the United States. In Germany, the figure was far higher.

Mangano believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug’s use with kidney failure requiring dialysis and increased death of those patients. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” says Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month,” he tells Pelley.

In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano’s results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. “The [Bayer] representatives at the meeting…should have disclosed fully to the FDA that a study was done…even put the meeting in abeyance until the data were found or discussed,” Mangano tells Pelley. “Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin,” he says.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,” he tells Pelley.

Bayer was also made aware of Trasylol’s potential to harm kidneys early in the drug’s development, according to a German scientist. Dr. Juergen Fischer, the director of the Institute of Experimental Medicine at the University of Cologne, near the German city where Bayer is headquartered, found the drug caused severe kidney damage in animals. He said he told Bayer about his results in the early 1980s, but, “I felt that Bayer wasn’t interested to examine these side effects,” he says. “There was no study organized to look at these side effects specially,” Fischer says.

The drug has always carried a warning of various side effects, including renal (kidney) effects.

Neither Bayer nor the FDA would speak to 60 Minutes for this story. Bayer sent a letter stating, in part: “The available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.”

The company plans to assess whether the drug can be remarketed after further research.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909